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NEWARK
– The State Board of Medical Examiners,
a licensing board within the Division of
Consumer Affairs, has publicly disciplined
three doctors who did not disclose their
personal financial interests in the success
of a medical device while they participated
in clinical trials of the device.
The
Board of Medical Examiners reprimanded Drs.
Richard A. Balderston, Thomas J. Errico,
and Jeffrey A. Goldstein for committing
professional misconduct by not disclosing
to their research institutions their financial
interests in the ProDisc spinal disc device.
The ProDisc device was a spinal disc replacement
developed to eliminate the need for spinal
fusion surgery. The doctors received payments
tied to certain milestones including FDA
approval achieved in the clinical study.
The Board also ordered each physician to
complete a medical ethics course. It assessed
civil penalties plus cost reimbursements
against Errico and Goldstein.
“Impartial
and objective diagnoses and treatment recommendations
are essential to maintaining the public’s
trust in their doctors. The undisclosed
conflicts of interest on the part of these
doctors undercut public trust in the medical
profession. The Board has acted to maintain
the integrity and high ethical standards
that the public rightfully expects from
their doctors,” Attorney General Paula
T. Dow said.
Goldstein
and Errico were involved in clinical studies
of the ProDisc device at the NYU Medical
Center and Hospital for Joint Disease but
failed to disclose their financial interest
in the device to the University as required.
Balderston failed to disclose his financial
interest in the ProDisc device to the University
of Pennsylvania’s Pennsylvania Hospital
as it required while he was the clinical
investigator of the device there.
Physicians
are required to disclose any financial payments
in excess of $10,000 that they have received
from medical device manufacturers when applying
for renewal of their licenses. Goldstein
and Errico answered “no” to
the question asking whether each had received
such a payment when, in fact, they had.
“Let
there be no doubt that doctors are obligated
to provide truthful responses on their license
renewal forms,” said Thomas R. Calcagni,
Acting Director of the State Division of
Consumer Affairs, “or face the consequences.”
The
Board assessed $60,000 in civil penalties
and $17,500 in cost reimbursements against
Errico. Goldstein was assessed $30,000 in
civil penalties and $10,000 in cost reimbursements.
All three must provide proof of successfully
completing a Board-approved ethics course.
Deputy
Attorney General Kim D. Ringler represented
the State in reaching Consent Orders with
the physicians.
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